Dual end bellow prosthesis insertion device

ABSTRACT

An apparatus and method for inserting prosthesis implants into apatient pocket. The apparatus has three openings including a prosthesis opening and two implant insertion openings. The apparatus prevents infection; eases insertion and placement; and reduces complications. In use, the first implant insertion end of the bellow is placed through the patient incision while allowing the bellow to be manipulated to force the first implant into a surgical pocket of a patient. Then the bellow is rotated 180 degrees so that the second implant insertion end becomes the opening through which the second implant is inserted into the second incision while allowing the bellow to be manipulated to force the second implant into a surgical pocket.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Non-Provisional patentapplication Ser. No. 15/661,427 filed on Jul. 27, 2017, entitled “DualEnd Bellow Prosthesis Insertion Device,” which is a continuation-in-partof U.S. Non-Provisional patent application Ser. No. 15/179,983 filed onJun. 11, 2016, entitled “Asymmetrical Dual Proximal Insertion Bellow,”which is a non-provisional and claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No. 62/348,338 filedon Jun. 10, 2016, entitled “Opposing Proximal Insertion Ends ImplantDevices,” both of which are incorporated by reference in their entirety.

FIELD OF THE DISCLOSURE

The present disclosure relates to an apparatus and method of safelyinserting a prosthesis into a human body.

BACKGROUND

Breast implants are a manufactured prosthesis used in cosmetic andreconstructive surgery. A breast implant has an outer casing or membranethat is filled with a fluid such as saline or a gelatinous cohesivesilicone. Currently only about thirty percent (30%) of breast implantprocedures are performed with an insertion device. An insertion deviceimproves both the sterility of the surgical procedure and the patientoutcome. Without an insertion device, the surgeon makes the incision,creates a pocket for the implant, opens the incision with a retractorand then manually pushes the implant into the pocket.

Different than a silicone implant, a saline implant is inserted into thepocket in an empty configuration. Once placed in the pocket, the surgeontakes the additional step of filling the empty implant with a salinesolution using a fill tube. The incision is made in one of four places:in the armpit, in the breast fold, in the navel, or around the areola.Except for the navel insertion, one incision is made for each implant.It is preferable that the incision be as short as possible. Shorterincisions are less unsightly. This goal of a shorter incision is easierto accomplish with a saline implant. A saline implant is relatively easyto insert through a short incision, as the implant is unfilled andtherefore small as it passes through the incision. For these inflatableimplants, the surgeon rolls up the implant like a cigar and pushes itthrough the incision and into the pocket. In contrast, silicone implantsare prefilled by the manufacturer resulting in a more difficult andcomplication-susceptible operation. For these pre-filled implants, theprocedure requires a longer incision length.

After the initial incisions, the surgeon dissects a path through thetissue to the desired destination of the implant. Once that path hasbeen created, a pocket is created for the implant superficial or deep tothe pectoralis major muscle. The pocket may be formed in one of twoplaces under the breast: subglandular (between the breast tissue andpectoralis major muscle) or subpectoral (under the pectoralis majormuscle). The subglandular position places the prosthesis directly behindthe mammary gland and in front of the pectoralis major muscle.Subpectoral places the implant partially under the pectoralis majormuscle. Due to the shape and position of the pectoralis major muscle, aportion of the implant is not covered by the muscle.

Secondary surgery is common for patients with breast implants. Patientswith breast implants may require surgery to change the placement (fromsubglandular to subpectoral or vice versa), correct palpable folding ofthe implant, remove a ruptured implant, treat infection, bleeding,breast pain, contracted scar tissue forming around the implant andcollections of fluid around the implant. These additional surgeries haverisks due to anesthesia, infection and bleeding. The overall secondaryoperation complication rate is about 15-18% for silicone gel breastaugmentation within 3 years of the initial operation and up to 36-42% by10 years from the initial breast implant surgery. Many re-operations arerelated to implant rupture (leakage), bleeding or capsular contracture.The major cause of re-operation after breast augmentation surgery iscapsular contracture caused by shrinkage or contracture of the sac orcapsule the body naturally forms around the implant.

Cellulitis, a skin-based infection, occurs in 2%-4% of patients, withsome surgeons reporting much higher rates, and is usually from thebacteria normally present on the skin. Symptoms of infection may includefever, pain, swelling and redness. To reduce infection, surgeons give asingle dose of antibiotics before the surgery, and use an antibioticsolution in the wound before implant placement. The antibiotic solutionmay double as the lubrication to allow easier insertion of the implantinto the pocket. However, surgeons can reduce the rate of capsularcontracture and infection down further by preventing the implant fromtouching the patient's skin during the insertion of the breast implant.

The implant insertion devices heretofore known suffer from severaldisadvantages:

-   -   1. The surgeon uses a single insertion end of the device to        insert both implants exposing the second incision to bacterial        contamination from the insertion device end touching the skin of        the initial (first) incision and delivering bacteria into the        second incision resulting in cellulitis, infection and or        capsular contraction;    -   2. Requires the surgeon to resize the insertion device        mid-operation to match two different implant sizes;    -   3. The opening through which the implant is loaded into the        device is large enough for the implant to inadvertently slip out        of the device resulting in bacteria on the skin touching the        implant; and    -   4. The high cost of current implant insertion devices encourages        re-use despite the manufacturer recommendation not to do so.

SUMMARY

Embodiments of the present disclosure may provide a system and method toinsert two prostheses into a patient with maximum sterility. The methodallows the surgeon to use the same size or two different size implantswith a single device where a different end of the device is used toinsert a single implant.

Accordingly, besides the objects and advantages of the system for abreast implant insertion device described above, several objects andadvantages of the present disclosure may provide:

-   -   a) means to further improve sterility by preventing the device        end from touching the patient's skin and then being inserted        into a second incision;    -   b) a device for a procedure using two different size implants;    -   c) a simplified insertion method;    -   d) means to reduce anesthesia time;    -   e) a device that secures the implant safely in the device such        that it will not become dislodged;    -   f) a single device that can be used for all sizes of implants;        and    -   g) an easier manipulation of the implant.

Further objects and advantages of the present disclosure will becomeapparent from a consideration of the drawings and the ensuingdescription of the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of this disclosure, reference is nowmade to the following description, taken in conjunction with theaccompanying drawings, in which:

FIG. 1 depicts a top side perspective view of a bellow according to anembodiment of the present disclosure;

FIG. 2 depicts a bottom view of a bellow according to an embodiment ofthe present disclosure;

FIG. 3 depicts a top side view of an unassembled bellow according to anembodiment of the present disclosure;

FIG. 4A depicts a top view of an unassembled bellow folded along theabutted edges according to an embodiment of the present disclosure;

FIG. 4B depicts a top view of a bellow showing the base fold assembledover the initial fold according to an embodiment of the presentdisclosure;

FIG. 4C depicts a top view of a bellow with the internal tab foldedthrough prosthesis opening after the prostheses are inserted accordingto an embodiment of the present disclosure;

FIG. 4D depicts a top view of a bellow with the exterior tab beingfolded over the prosthesis opening according to an embodiment of thepresent disclosure;

FIG. 5 depicts a front perspective view of a bellow with an implantbeing inserted through the prosthesis opening and into the deviceaccording to an embodiment of the present disclosure;

FIG. 6 depicts a side perspective view of the operating team addinglubricant to one end of the bellow according to an embodiment of thepresent disclosure;

FIG. 7A depicts a left side perspective view of a bellow with first endinserted into the left patient incision according to an embodiment ofthe present disclosure; and

FIG. 7B depicts a rights side perspective view of a rotated bellow withthe second end inserted into the right patient incision according to anembodiment of the present disclosure.

REFERENCE NUMERALS IN DRAWINGS

10 patient

20 patient's incision, opening

22 patient's breast

24 patient's implant pocket

25 patient's skin tissue

30 prosthesis, breast implant, implant

40 bellow

42 first insertion end

44 second insertion end

46 base fold

48 initial fold

50 exterior tab

52 internal tab

54 prosthesis opening

56 seal folds

57 tab-side seal tuck

58 abutted-side seal tuck

60 lubricant

70 retractor

72 retractor handle

74 retractor handle proximal end

76 retractor proximal end lip

DETAILED DESCRIPTION

Embodiments of the present disclosure may provide a dual end bellowprosthesis insertion device wherein each end may be trimmed as needed toaccommodate breast implants that may be the same size or may bedifferent sizes. It should be appreciated that the ends may have thesame size opening in some embodiments of the present disclosure, butthere may be other embodiments where one end is larger than the otherend. There may be side flaps through which the implants may be insertedin the bellow, and these side flaps may be in the middle so that eachimplant may be placed in the bellow through a single opening, althoughonly one implant may be loaded at a time. The implant may be insertedinto the breast pocket, and the bellow may be turned around so that thesecond implant may be loaded into the bellow and inserted into thebreast pocket through a second, unused end of the bellow. This may keepskin bacteria from being transferred from one implant pocket skin edgeto the second implant pocket, which can occur if the two implants areinserted into the implant pockets using the same implant insertiondevice opening.

Referring now to FIG. 1, the top side perspective view of bellow 40 ismanufactured with a sheet material such as plastic or a flexible,surgical-grade nylon. The plastic may be strengthened or reinforced withfibers. Bellow 40 may be clear, or semi-transparent, to allowobservation of prosthesis 30 moving from bellow 40 into patient pocket24.

Bellow 40 may have three openings: first insertion end 42 for insertinga range of implant sizes into incision 20; second insertion end 44 forinsertion of a range of implant sizes into incision 20; and prosthesisopening 54, surrounded by exterior tab 50 and internal tab 52, forinserting prosthesis 30 into bellow 40. Each end 42, 44 may beconsidered an implant insertion end because bellow 40 is rotated duringsurgery so that each end 42, 44 is sequentially inserted in incision 20.FIG. 1 shows tabs 50, 52 located central to ends 42 and 44 and internaltab 52 pushed through prosthesis opening 54 to prevent the implant frompassing to the outside of bellow 40, and exterior tab 50 folded overprosthesis opening 54. Exterior tab 50 may be folded and held in placeby a surgeon's hands, friction or attached by glue, adhesive, heat bond,surgical tape or other coupling mechanism. While FIG. 1 shows both tabs50, 52 folded into the working position, bellow exterior tab 50 andbellow internal tab 52 may initially be presented to the surgeon withboth tabs 50, 52 outside of bellow 40 and surrounding prosthesis opening54. While the preferred embodiment shows different sized tabs 50, 52 todistinguish exterior tab 50 from internal tab 52, tabs 50, 52 may be ofthe same size in embodiments of the present disclosure.

Bellow 40 may be assembled using seal tucks 56 which comprise two (2)tab-side seal tucks 57, and one (1) abutted-side seal tuck 58. In apreferred embodiment, the assembly may be done prior to packaging andshipping to the surgeon. In an alternate embodiment, seal tucks 56 maybe sealed to base fold 46 by the patient's operating team. See FIG. 4Bfor additional illustration of the assembly using seal tucks 56.

Bellow 40 prevents breast implant 30 from touching the patient's skintissue 28, prevents only one insertion end 42 or 44 from being used inboth (right and left breast) incisions 20, and prevents damage toimplant 30 during implant insertion. Bellow 40 may be manufactured toaccommodate any breast implant 30 shape, volume, and diameter. Eachinsertion end 42, 44 may be trimmed by the surgeon to allow insertion ofa range of implant 30 sizes. The manufacturer may also require orsuggest two specific skin incision 20 lengths to allow insertion of theimplant through bellow 40 into incision 20. The specifications take theburden off the surgeon to try to make shorter incisions 20.

FIG. 2 shows a bottom view of the manufactured version of bellow 40 oncebellow fold 48 is folded over base fold 46 along the abutted seam andthree seal tucks 56 are adhered to base fold 46. Bellow 40 comprisesinitial fold 48 partially sealed on the periphery to base fold 46 sothat it leaves implant insertion ends 42, 44, bellow prosthesis opening54, bellow exterior tab 50 and bellow internal tab 52.

Turning to FIG. 3, the illustration depicting a perspective view ofunassembled bellow 40. Bellow 40 comprises two simple, convex, irregularhexagons folds 46, 48 with opposing prosthesis insertion tabs 50, 52. Ina preferred embodiment, tabs 50, 52 are located centrally and opposingthe abutted sides of manufactured bellow 40. In a preferred embodiment,as shown in FIGS. 3-4D, base fold 46 is manufactured abutted againstinitial fold 48 along either edge opposing the tabbed side of folds 46,48. In a second embodiment, initial fold 48 and base fold 46 would beseparately manufactured and assembled together at a later stage.

In the preferred embodiment, bellow 40 would be folded along an abuttededge and manufactured with three seal tucks 56 along: (a) initial fold48 abutted-side edge from the abutment to second insertion end 44; (b)initial fold 48 tab-side edge from exterior tab 50 to first insertionend 42; and (c) initial fold 48 tab-side edge from exterior tab 50 tosecond insertion end 44.

In the second embodiment, bellow 40 would be manufactured with separatedinitial fold 48 and base fold 46, stacked over each other and assembledwith four seal tucks 56 along: (a) initial fold 48 abutted-side edgefrom the abutment to first insertion end 42; (b) initial fold 48abutted-side edge from the abutment to second insertion end 44; (c)initial fold 48 tab-side edge from exterior tab 50 to first insertionend 42; and (d) initial fold 48 tab-side edge from exterior tab 50 tosecond insertion end 44.

Bellow seal tucks 56 may be folded over opposing fold 46, 48 andattached by glue, adhesive, heat bond, surgical tape or other couplingmechanism.

In another embodiment, seal tucks 56 may be replaced with a simple seamalong the edges to bind initial fold 48 and base fold 46 with glue,adhesive, heat bond, surgical tape or other coupling mechanism.

FIGS. 4A to 4D show the assembly of bellow 40. In FIG. 4A, the patternis folded along the abutted edge so that base fold 48 and initial fold46 are stacked over each other with tabs 50, 52 pointing in the samedirection.

Then in FIG. 4B, seal tucks 56 are folded over opposing fold 46, 48 andsealed to opposing fold 46, 48 with any desired manufacturing sealingtechnique.

With breast implant 30 in place inside bellow 40, FIG. 4C, internal tab52 is pushed through prosthesis opening 54. Internal tab 52 preventsimplant 30 from inadvertently ejecting through prosthesis opening 54during the operation.

In FIG. 4D, with the internal tab 52 inside prosthesis opening 54,exterior tab 50 may be pushed over the top surface of opposing fold 46,48. Exterior tab 50 may be secured to opposing fold 46, 48 with thesurgeon's hands, surgical tape, heat seal, instant glue, or other formsof seals. Adhered seal 50 opposes prosthesis opening 54 and joinsinitial fold 48 and base fold 46.

As illustrated in FIG. 5, in the preferred embodiment, a coating ofsurgical lubricant 60 may be used on implant 30 and the inner surface ofbellow 40. As an alternative, bellow 40 may be provided with a coatingthat becomes slick when wet. In still another alterative, prosthesis 30may be provided with a slick surface, such as surgical lubricant 80. Thesurgeon also has the option of applying lubricant 60 to prosthesis 30directly before inserting into bellow 40. Lubricant 60 may also act asan antibiotic solution.

After lubrication, breast implant 30 is inserted into bellow 40 by thesurgeon and nurse. To do so, the nurse opens bellow prosthesis opening54 by separating tabs 50, 52, and the surgeon slides prosthesis 30through bellow prosthesis opening 54. The surgeon would then foldinternal tab 52 into bellow prosthesis opening 54 to prevent breastimplant 30 from moving back out of opening 54. Exterior tab 50 may beleft extended or folded over opposing fold 46, 48. If desired, exteriortab 50 may be sealed to opposing fold 46, 48. In a preferred embodiment,inserting prosthesis 30 into bellow 40 would be completed prior toinserting retractor 70 into patient incision 20. However, a surgeoncould perform this step while bellow 40 is inserted in incision 20. In apreferred embodiment, the surgeon would insert one prosthesis 30 intobellow 40 at a time.

In FIG. 6, the surgical team inserts lubricant 60 in opposing end 42, 44of end 42, 44 inserted in incision 20. Liquid lubricant 60 surroundsbreast implant 30 inside bellow 40. An antibiotic solution may be usedas lubricant 60.

FIG. 7A shows patient 10 positioned in a supine position prior toincision 20 being made in the patient's skin tissue 28. In the figure,incision 20 is cut in left-side inferior breast 22 crease. With incision20 opened, the surgeon then forms pocket 24 in one of two places underbreast 22: subglandular (between breast 22 tissue and pectoralis majormuscle) or subpectoral (deep to the pectoralis major muscle). Pocket 24is sized to match prosthesis 30. By manipulating retractor handle 72,retractor handle proximal end 74 and retractor proximal lip 76 areinserted into incision 20 to both retract incision 20 and hold incision20 open.

Retractor 70 assembly comprises handle 72 located in the center,retractor handle proximal end 74, and retractor handle proximal end lip76. Retractor 70 may have various shapes and sizes to match theapplication or surgeon preferences. Handle 72 of retractor 70 is bent orangled on the ends relative to the intermediate portion. Proximal end 74of retractor 70 has lip 76 that is angled relative to end 74. Retractor70 is made of metal, such as stainless steel, but may also bemanufactured in a surgical plastic in other embodiments of the presentdisclosure.

Retractor proximal end 74 is structured and arranged to be insertedthrough incision 20 into pocket 24 of patient 10. Proximal end lip 76helps maintain proximal end 74 of retractor 70 beneath skin tissue 28 ofpatient 10.

Retractor 70 extends laterally from bellow 40, so as not to interferewith the surgeon manipulating bellow 40, with the proximal ends ofretractor 74 and proximal end lip 76 inserted into incision 20 andlocated under skin tissue 28 and moved to retract incision 20. Implantinsertion ends 42, 44 of bellow 40 may be lubricated with lubricant 60and inserted into open incision 20.

Bellow 40, distal to incision 20, is squeezed and/or twisted to forceprosthesis 30 toward insertion end 42, 44 of bellow 40 and into pocket24. Prosthesis 30 deforms to fit through second insertion end 44.

Once prosthesis 30 is located inside pocket 24, retractor 70 is removedfrom incision 20, followed by bellow 40. Incision 20 is then closed.

Finally, in FIG. 7B, showing a right-side of a patient, retractor 70 isinserted in second breast 22 incision 20 and moved to retract incision20. Bellow 40 is then rotated so that the second unused implantinsertion end 42 or 44 is introduced to incision 20 of second breast 22.The other implant insertion end 42 or 44 may be lubricated withlubricant 60 and inserted into open incision 20.

Bellow 40 is squeezed and/or twisted to force prosthesis 30 towardinsertion end 42, 44 of bellow 40 and into pocket 24. Prosthesis 30deforms to fit through insertion end 42,44.

Once prosthesis 30 is located inside pocket 24, retractor 70 is removedfrom second incision 20, followed by bellow 40. Second incision 20 isthen closed.

If bellow 40 is designed for reuse, it is subjected to sterilizationprocedures. If bellow 40 is designed for single use, it is disposed ofOne embodiment of bellow 40 and method is that implant insertion ends42, 44 may be properly sized during manufacture with respect to eachother so that smallest breast implants 30 will fit through firstinsertion end 42 and the larger range of implants 30 may be insertedthrough second insertion end 44. This allows the proper pressure to beapplied to each range of implants 30 as they deform through insertionends 42, 44.

Implant 30 is subject to damage if implant 30 is mishandled. Possiblemishandling includes subjecting implant 30 to undue stresses orpressures, such as may be caused by attempting to squeeze implant 30through implant insertion end 42, 44 that is too small, and folding ofthe external silastic shell, internal fracture of the cohesive siliconegel. A surgeon may make incision 20 in patient 10 that is too short forimplant 30 and thus too much force is required to squeeze implant 30into pocket 24. With bellow 40, implant 30 is protected from damage bythe provision an adequate skin incision length and of the properly sizedsecond insertion end 44. The major complication with implants 30 iscapsular contracture thought to be due to sub-clinical infection.Sub-clinical infection is most likely caused by pushing implant 30through skin incision 20, dragging natural skin 28 bacteria (stillpresent after proper skin 28 preparations) into pocket 24 surgicallycreated for implant 30. Use of bellow 40 prevents implant 30 from comingin contact with skin tissue 28 during the insertion process.

Although the present disclosure and its advantages have been describedin detail, it should be understood that various changes, substitutionsand alterations can be made herein without departing from the spirit andscope of the disclosure as defined by the appended claims. Moreover, thescope of the present application is not intended to be limited to theparticular embodiments of the process, machine, manufacture, compositionof matter, means, methods and steps described in the specification. Asone of ordinary skill in the art will readily appreciate from thedisclosure, processes, machines, manufacture, compositions of matter,means, methods, or steps, presently existing or later to be developedthat perform substantially the same function or achieve substantiallythe same result as the corresponding embodiments described herein may beutilized according to the present disclosure. Accordingly, the appendedclaims are intended to include within their scope such processes,machines, manufacture, compositions of matter, means, methods, or steps.

In the foregoing description, and the following claims, method stepsand/or actions are described in a particular order for the purposes ofillustration. It should be appreciated that in alternate embodiments,the method steps and/or actions may be performed in a different orderthan that described. Additionally, the methods described above may beembodied in machine-executable instructions stored on one or moremachine-readable mediums, such as disk drives, thumb drives or CD-ROMs.The instructions may be used to cause the machine (e.g., computerprocessor) programmed with the instructions to perform the method.Alternatively, the methods may be performed by a combination of hardwareand software. While illustrative and presently preferred embodiments ofthe present disclosure have been described in detail herein, it is to beunderstood that the inventive concepts may be otherwise variouslyembodied and employed, and that the appended claims are intended to beconstrued to include such variations, except as limited by the priorart.

Benefits, other advantages, and solutions to problems have beendescribed herein with regard to specific embodiments. However, theadvantages, associated benefits, specific solutions to problems, and anyelement(s) that may cause any benefit, advantage, or solution to occuror become more pronounced are not to be construed as critical, required,or essential features or elements of any or all the claims of thepresent disclosure. As used herein, the terms “comprises”, “comprising”,or any other variation thereof, are intended to cover a non-exclusiveinclusion, such that a process, method, article, or apparatus composedof a list of elements that may include other elements not expresslylisted or inherent to such process, method, article, or apparatus.

From the description above, several advantages become evident for thedual end bellow prosthesis insertion device. Embodiments of the presentdisclosure may provide all new benefits for participating partiesincluding manufacturers, patients and surgeons:

-   -   a) allow manufactures to ship a single breast implant insertion        device for a pair of implants;    -   b) allows manufacturers to ship a single size bellow for all        implant sizes;    -   c) allows patients a lower risk of complications;    -   d) allows physician to prevent contamination by skin bacteria,        gross infection from using a single implant insertion end twice,        resulting in infection and/or capsular contracture;    -   e) allows physician to eliminate damage to the implant during        the insertion process;    -   f) allows physician a simplified insertion process;    -   g) speeds the implant insertion surgery.

Although the present disclosure and its advantages have been describedin detail, it should be understood that various changes, substitutionsand alterations can be made herein without departing from the spirit andscope of the disclosure as defined by the appended claims. Moreover, thescope of the present application is not intended to be limited to theparticular embodiments of the process, machine, manufacture, compositionof matter, means, methods and steps described in the specification. Asone of ordinary skill in the art will readily appreciate from thedisclosure, processes, machines, manufacture, compositions of matter,means, methods, or steps, presently existing or later to be developedthat perform substantially the same function or achieve substantiallythe same result as the corresponding embodiments described herein may beutilized according to the present disclosure. Accordingly, the appendedclaims are intended to include within their scope such processes,machines, manufacture, compositions of matter, means, methods, or steps.

1. An apparatus for inserting a prosthesis through an incision into asurgical pocket, comprising: a bellow comprising two separate implantinsertion ends and a prosthesis opening surrounded by tabs, the bellowbeing semi-rigid and structured and arranged to receive a breast implantthrough the prosthesis opening, wherein the bellow is assembled withtab-side seal tucks and an abutted-side seal tuck.
 2. A method forinserting a prosthesis formed of a first implant and a second implantthrough an incision into a surgical pocket, comprising: using a bellowincluding a prosthesis opening, a first implant insertion end, and asecond implant insertion end, inserting the first implant insertion endthrough the incision while manipulating the bellow to force the firstimplant into the surgical pocket; rotating the bellow 180 degrees sothat the second implant insertion end becomes an opening through whichthe second implant is inserted into the incision; and inserting thesecond implant into the insertion while manipulating the bellow to forcethe second implant into the surgical pocket.